510(k) K070642 ยท CAF Nebulizer (Direct Patient Interface)
AERONEB PROFESSIONAL NEBULIZER SYSTEM
| Applicant | Aerogen (Ireland), Ltd., Dangan Galway, IE |
| Decision | Substantially Equivalent, May 7, 2007 |
| Received | Mar 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070642
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.